Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device (TAB-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by InterValve, Inc.
Sponsor:
Information provided by (Responsible Party):
InterValve, Inc.
ClinicalTrials.gov Identifier:
NCT02099942
First received: March 18, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care


Condition Intervention
Aortic Valve Stenosis
Device: V8 Balloon Aortic Valvuloplasty (BAV) Catheter

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)

Resource links provided by NLM:


Further study details as provided by InterValve, Inc.:

Primary Outcome Measures:
  • Efficacy Endpoint: V8 Device Performance [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
    Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.

  • Safety Endpoint: Serious Adverse Events (SAE) [ Time Frame: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.) ] [ Designated as safety issue: Yes ]
    The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).


Secondary Outcome Measures:
  • Efficacy Endpoint: Intra-Procedure Hemodynamic Changes [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
    Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).

  • Efficacy Endpoint: Post-Procedure Hemodynamic Changes [ Time Frame: Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.) ] [ Designated as safety issue: No ]
    Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).

  • Safety Endpoint: Aortic Valve (AV) Block at Discharge [ Time Frame: At discharge, which is expected to be within 72 hours procedure. ] [ Designated as safety issue: Yes ]
  • Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up [ Time Frame: 6-Month Follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: V8 Balloon Aortic Valvuloplasty (BAV) Catheter

    The V8 device can be used for BAV as follows:

    • as stand-alone intervention
    • as a bridge to transcatheter aortic valve replacement (TAVR)
    • as a bridge to surgical aortic valve replacement (SAVR)
    • as an intraprocedural predilatation prior to TAVR
Detailed Description:

The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.

BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic - Patients at each enrolling clinic who are to be treated with the InterValve V8 device for balloon aortic valvuloplasty (BAV) are eligible for enrollment.

Criteria

Inclusion Criteria:

  • Symptomatic severe aortic stenosis (AS) patients who are not suitable candidates for aortic valve replacement surgery at the time of BAV procedure.
  • Subject meets the Indication For Use.
  • Probable survival to hospital discharge.
  • Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form. Alternatively, the legal guardian of the patient is able to give consent to participate.

Exclusion Criteria:

  • Patient has undergone previous AVR
  • Greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned BAV or intra-procedural predilation TAVR procedure
  • Non-valvular AS
  • Known congenital AV abnormality (e.g., bicuspid AV)
  • Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off vasopressors or <90 mmHg on vasopressors.
  • Bacterial endocarditis ≤ 12 months prior to planned BAV procedure
  • Unable to take aspirin (acetyl salicylic acid, ASA) or thienopyridine
  • Any illness or condition which, in the Investigator's judgment, will compromise patient safety, or interfere with the interpretation of the treatment results
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099942

Locations
United States, California
University of Southern Califormia Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Rene Rivers, unk    323-422-6192    Brenda.Rivers@med.usc.edu   
Contact: Christine Tam, RN, MS, CCRP    (310) 237-3119    christine.tam@med.usc.edu   
Good Samaritin Hospital Recruiting
Los Angeles, California, United States, 90017
Contact: Cecile Mayoralgo, RN    213-977-2238    cmayoralgo@goodsam.org   
United States, Minnesota
Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation) Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Melissa Buescher, MPH    612-863-5507    melissa.buescher@allina.com   
Contact: Lisa Tindell, BSN    (612) 863-3816    lisa.tindell@allina.com   
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232-8802
Contact: Carol Watts    615-322-9845    carol.watts@vanderbilt.edu   
Contact: Mary Lou Haynes    615-343-9071    marylou.haynes@vanderbilt.edu   
Centennial Heart Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Casey Kappenman    615-329-7460    casey.kappenman@scresearch.net   
United States, Virginia
Henrico's Doctors' Hospital Not yet recruiting
Richmond, Virginia, United States, 23229
Contact: Abi Koehler    804-289-4700    abigail.koehler2@scresearch.net   
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Michaela Galapon       mgalapon@cardiology.washington.edu   
Sponsors and Collaborators
InterValve, Inc.
  More Information

No publications provided

Responsible Party: InterValve, Inc.
ClinicalTrials.gov Identifier: NCT02099942     History of Changes
Other Study ID Numbers: 1058-001
Study First Received: March 18, 2014
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by InterValve, Inc.:
Balloon Aortic Valvuloplasty
Valvuloplasty
Transcatheter Aortic Valve Replacement
Surgical Aortic Valve Replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 16, 2014